Warm Humid Gas Insufflation for Appendix Removal by Minimally Invasive Surgery Warm Humid Insufflation for Appendix Removal by Minimally Invasive Surgery Trial (WARMIST)
WARMIST
Warm Humidified Insufflation for Laparoscopic Appendicectomy in Children: a Randomised Controlled Trial
1 other identifier
interventional
190
1 country
1
Brief Summary
In laparoscopic (key-hole) surgery, the use of cold dry carbon dioxide gas to inflate the abdominal cavity for the creation a clear operating field, results in damage to the cavity lining, known as the peritoneum. This has been associated with negative effects on post-operative recovery. Adult studies using warm humidified insufflation gas have indicated possible decreased post-operative pain, reduced narcotic analgesia requirements, decreased fogging of the laparoscopic camera lens, and reduced time to return to normal activities. Cold dry gas during laparoscopic surgery also has potential to cause abnormal decrease in body core temperature (hypothermia). This has been established by trials in adult humans and animal models. The WARMIST study aims to investigate for whether warm humid gas insuflation during laparoscopic removal of the appendix in children reduces intraoperative temperature variations, post-operative pain (indicated by morphine usage and pain scores), length of hospital stay and degree of camera lens fogging, and speed post-operative recovery compared to using cold dry gas insufflation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2009
CompletedFirst Posted
Study publicly available on registry
December 8, 2009
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedJune 25, 2010
October 1, 2009
1 year
December 7, 2009
June 24, 2010
Conditions
Outcome Measures
Primary Outcomes (2)
Post-operative Morphine equivalent analgesia use
PACU, Post-operative 12 hours, Post-operative 24 hours, Post-operative 48 hours, Duration of hospital stay
Peri-operative Core Body Temperature Variation
Intra-operative, Duration of stay in PACU
Secondary Outcomes (5)
Pain scores measured by Visual Analogue Scale
Pre-operative baseline and Post-operative 2, 4, 6, 8, 10, 12, 24, 48 hours
Post-operative Return to Normal Daily Activities
Post-operative Day 10 Recovery Questionnaire
Severity of Post-operative Nausea and Vomiting as indicated by Antiemetic use
Post-operative Day 0, Day 1, Day 2, Day 3
Peri-operative Complications (operative and disease-related)
Up to 6 weeks post-operatively
Severity of Laparoscopic Camera Lens Fogging
Intra-operative
Study Arms (2)
Dry Cold
PLACEBO COMPARATORDry (0% relative humidity) and cold (20 degrees Celsius - Room Temperature) carbon dioxide gas intraperitoneal insufflation for laparoscopic appendicectomy
Humidification
EXPERIMENTALHumidified (98% relative humidity) and warm (37 degrees Celsius) carbon dioxide gas intraperitoneal insufflation for laparoscopic appendicectomy
Interventions
Humidified warm carbon dioxide gas insufflation during laparosopic procedure
Eligibility Criteria
You may qualify if:
- Healthy volunteers aged 8-14 years presenting to Starship Children's Hospital (Auckland, New Zealand) within the study period diagnosed clinically with acute appendicitis requiring diagnostic laparoscopy +/- appendicectomy.
You may not qualify if:
- Consent to participate in study not obtained, partial or total blindness, unable to speak and read sufficient English, presence of any abdominal prostheses, diagnosis of mental retardation, developmental delay, neuromuscular impairment, attention-deficit disorder, chronic pain, or psychiatric illness, immunosuppression, allergy to morphine, and history of previous abdominal surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Starship Children's Hospital
Auckland, New Zealand
Related Publications (1)
Yu TC, Hamill JK, Liley A, Hill AG. Warm, humidified carbon dioxide gas insufflation for laparoscopic appendicectomy in children: a double-blinded randomized controlled trial. Ann Surg. 2013 Jan;257(1):44-53. doi: 10.1097/SLA.0b013e31825f0721.
PMID: 22824858DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 7, 2009
First Posted
December 8, 2009
Study Start
March 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
June 25, 2010
Record last verified: 2009-10